Generic TRADE Side effects / Contraindications CI ...

[Pages:6]Erectile Dysfunction Comparison Chart (ED) Treatment Chart 1,2,3,4,5,6,7,8 Canadian 2006

S Downey, B Jensen, L Regier ? RxFiles.ca

June 10

Generic/TRADE

Class /

Side effects / Contraindications CI

= therapeutic use / Comments /

INITIAL;MAX; $

(Strength & forms) Pregnancy category 9

Drug Interactions DI / Monitor M

USUAL DOSE 8 doses

Sildenafil

VIAGRA

=S

25, 50, 100mg tab

10,11,12,13,14 ; approved 1999

(Revatio 20-80mg tab tid $1050 per month,new:USAIVformPAH)

Tadalafil

CIALIS

=T

2.5,5,10,20mg tab15,16

(Adcirca20-40mgtabod FDA'09;

USA is IV formPAH)

Vardenafil

LEVITRA =V 5,10, 20mg tab

17,18,19,20,21,22,23,24,25,26

Oral selective phosphodiesterase-5

PDE5 inhibitor:

-reduce catabolism of cGMP resulting in smooth muscle relaxation of the

corpus cavernosum and blood flow into penis (need sexual stimulation to produce actual erection) -considered FIRST LINE unless CI, but ~30% of men may still not respond to PDE5's monotherapy.

B

Common: flushing10%, diarrhea 4% , dizziness2%,

headache >10%,dyspepsia with S,V), myalgia (T=6%35), nasal congestion & rash 2% esp S ; GI upset dose-related &

visual disturbance (>10% at dose high), ?(smell, amnesia,hearing loss). [hot flashes if used in ]

Serious: rare MI & *priapism; QT prolongation ?V,

very rare cases of NAION23 ,?seizures, ?sickle cell crisis

CI: nitrates: hypotensive effect & heart rate (AVOID within 24h of S,V; 48h of T 31);

-1 blockers (if new pt or if given 4hrs) S >25mg ,T,V

Precautions: anatomical penis deformation; CV dx

(eg. arrhythmia,recent MI/stroke,uncontrolled HTN,

coronary ischemia, HF); risk of priapism* (eg,

sickle cell anemia, multiple myeloma, or leukemia); liver dx; multi BP meds; renal fx; NAION 27;

idiopathic,postencephalitic,symptomatic (Option: SSRI induced ED) (Onset similar: generally 30-60min V,S,T; as early as 10-15min V,S); S&T: pulmonary arterial HTN.

Peak effect: S &V ~1hr; T ~2hr; Duration: S&V~4-12hr T 36hr

DI: hypotension: -1 blockers (especially in new pt; avoid or space by >4hrs); nitrates (CI or caution); antihypertensives (esp. vasodilators) & alcohol

Nitrate washout period: S & V~24hr; T ~48hr. V:QT see QT chart p.17

levels of PDE5 by: CYP 3A4 inhibitors (azole antifungals, cimetidine, cipro, erythromycin/ macrolides, tacrolimus), doxycycline, grapefruit juice, isoniazid, protease inhibitors,

quinidine, verapamil. (PDE5:use lowest dose; S,V: Max interval q24h T: Max interval q72h) effect: enzyme inducers carbamazepine, phenytoin, phenobarb, rifampin; S&T by bosentan.

high fat meals may delay and reduce efficacy of S & V.

M:S,T= liver & renal fx, V=liver fx tests (Initial workup usually: glucose, lipid, TSH, ) testosterone

Dose Adjustments: >65years old: initial; S=25 mg T= by CrCl V=5mg

Liver dx: Initial S=25 mg, T=10mg V=5mg Renal dx CrCl : 4hr) tx=needle aspiration of penile blood;

intracavernosal inj phenyleprhine 200ug q5min up to 500ug if needed) 34

10-30mins pre-sex (dose depends on venous anatomy not ED etiology)

5ml vial

0.5-1ml/dose

compounded

Papaverine = Pv

30mg/ml inj. soln

(2ml vials)

Phentolamine = Pt

Rogitine, generic

5mg lypholized powder for injection

As adulterants in: Desire

Vasodilator

(non-selective PDE 2,3,4 inhibitor)

-produces generalized

arteriolar dilation &

smooth muscle relaxation

-can be combined with

prostaglandin &/or phentolamine

C

Alpha-Adrenergic

Blocker

-antagonizes anti-erectile sympathetic tone, perfusion

- poor efficacy alone so

usually combined with

prostaglandin &/or

papaverine

C

Common: abdominal discomfort, anorexia, constipation, diarrhea, nausea, vomiting, drowsiness, headache, vertigo, hypertension, tachycardia, pruritis, rash & blurred vision? Serious: acidosis, intercranial pressure,

hepatotoxicity & priapism*

CI: complete atrioventricular block Precautions: glaucoma, liver dx, recent MI, stroke,

Parkinsonism & sickle cell anemia

Common: chest pain, diarrhea, dizziness3%, headache3%, hypotension2%, nasal congestion10%, nausea, palpitations1%, HR1-7% & vomiting Serious: arrhythmia

CI: myocardial infarction, CAD, angina pectoris, hypersensitivity to phentolamine or mannitol, renal impairment, coronary or cerebral arteriosclerosis

Precautions: arrhythmia, cerebral vascular spasm or occlusion, hypertension, HR

idiopathic, postencephalitic & symptomatic (not FDA indication)

Papaverine in any ischemic type condition is not recommended. Do not use more than 3 times weekly or 2 days in succession. Combos: -0.5-1 mg phentolamine intracavernosal;

phentolamine & alprostadil by intracavernosal inj Consult Dr. if erection lasts more than 4 hours after self inj T?= 0.5-2hr DI: levodopa ( levodopa affect), ginkgo ( SE of papaverine)

M: intraocular pressure in glaucoma patients, liver fx

idiopathic, postencephalitic & symptomatic (not FDA indication)

Take one hour prior to sexual activity

Peak activity: 30-60min Onset of action: 30-40min Duration: 5-7hr

Compounded mixes may efficacy and pain associated with prostaglandin

DI: hypotension: beta blockers, tadalafil & vardenafil; disulfiram like rx with

alcohol; effect with ephedrine (OTC cough/cold products, diet & "wake-up" pills)

M: blood pressure changes, heart rate

30 mg

60mg

30mg-60mg intracavernosal over 1-2 min

$40 10x2ml

vials

Compounded Products Bi-mix inj = Pt + Pv

6ml vial = $60 0.5-1ml/dose

Tri-Mix inj =Pt + Pv + E1 in 3 strengths

$60-80 per 5ml vial 0.2-1ml per dose

TriMix also available in Transurethral gel

$40-120 / 5x1ml syr 0.5-1ml per dose

=dose for renal dysfx =scored tab =Non-formulary Sk =Exception Drug Status Sk =not covered by NIHB W=covered by NIHB ac=before meal BP=blood pressure cc=with meal CI=contraindication CrCl=creatinine clearance DI=drug interaction Dx=disease ED=Erectile

dysfx fx=function HF=heart failure HR=heart rate MI=myocardial infarction NAION=nonarteric ischemic optic neuropathy n/v=nausea/vomiting pc=after meal Pt=patient RT=room temp. Sx=symptom SE=side effect T?=half life Tx=treatment

Remedy for penile inj pain: Sodium bicarbonate to restore isotonicity. Other Meds: apomorphine42, testosterone 33,yohimbine 34 ? Prelox, surgical (eg. revascularization/penile prosthesis implantation)35 & vacuum devices~$350. * priapism=any erection lasting >4hr

Diagnosis: ED is a couple's entity. Involve partner; may be reasons not to tx Rule out: low sex drive, relationship & psychological problems Non Drug: Quit smoking, regular exercise avoid prolonged cycling >3hr/wk 36, excess wt, & alcohol consumption.

Drug induced: acetazolamide, alcohol, barbiturate, beta-blocker, carbamazepine, cimetidine, clonidine, cocaine, cyproterone, digoxin, finasteride, flutamide, ketoconazole, labetalol, lithium, MAOI,methadone,methyldopa,marijuana,methotrexate,opioid, phenytoin, phenothiazine, spironolactone, SSRI, TCA & thiazide. 46

See also: Sexual Dysfunction Chart:

Erectile Dysfunction Comparison Chart (ED) Treatment Chart

1 Fazio L, Brock G. Erectile dysfunction: management update. CMAJ. 2004 Apr 27;170(9):1429-37. 2 Therapeutic Choices 5rd Edition, 2007 3 Micromedex 2010 4 Basu A, Ryder RE. New treatment options for erectile dysfunction in patients with diabetes mellitus. Drugs. 2004;64(23):2667-88. 5 Anderson PC, Gommersall L, Hayne D, Arya M, Patel HR. New phosphodiesterase inhibitors in the treatment of erectile dysfunction. Expert Opin Pharmacother. 2004 Nov;5(11):2241-9. 6 Viera AJ, Clenney TL, et al. Newer pharmacologic alternatives for erectile dysfunction. Am Fam Physician. 1999 Sep 15;60(4):1159-66, 1169, 1172. Review. Erratum in: Am Fam Physician 2000 Apr 15;61(8):2344. 7 Montague DK, Barada JH, Belker AM, Levine LA, Nadig PW, Roehrborn CG, Sharlip ID, Bennett AH. Clinical guidelines panel on erectile dysfunction: summary report on the treatment of organic erectile dysfunction. The

American Urological Association. J Urol. 1996 Dec;156(6):2007-11. 8 Canadian Urological Association Guidelines Committee. Erectile dysfunction practice guidelines. Can J Urol. 2002 Aug;9(4):1583-7. 2006 Guidelines: 9 Briggs GG, Freeman RK, Sumner JY. Drugs in Pregnancy and Lactation 8th Edition. Williams & Wilkins, Baltimore, 2008. 10 Fink HA, Mac Donald R, Rutks IR, Nelson DB, Wilt TJ. Sildenafil for male erectile dysfunction: a systematic review and meta-analysis. Arch Intern Med. 2002 Jun 24;162(12):1349-60. 11 Carson CC, et al. Erectile response with vardenafil in sildenafil nonresponders: a multicentre, double-blind, 12-week, flexible-dose, placebo-controlled erectile dysfunction clinical trial. BJU Int. 2004 Dec;94(9):1301-9. 12 Raina R, Lakin MM, Agarwal A, Sharma R, et a.. Long-term effect of sildenafil citrate on erectile dysfunction after radical prostatectomy: 3-year follow-up. Urology. 2003 Jul;62(1):110-5. 13 Galie N, Ghofrani HA, Torbicki A, et al. Sildenafil citrate Therapy for Pulmonary Arterial Hypertension. N Engl J Med 2005;353:2148-57.(InfoPOEMs: Sildenafil improves the 6-minute walking distance by approximately 15% & leads to an

improvement in functional status for between 28% & 42% of patients with pulmonary arterial hypertension (number needed to treat = 2.5 - 4). It is reasonable to begin with 20 mg TID & only increase that dose if the drug is well tolerated & there is no clear response. (LOE = 1b) ) 14 Fries R, Shariat K, von Wilmowsky H, Bohm M. Sildenafil in the treatment of Raynaud's phenomenon resistant to vasodilatory therapy. Circulation. 2005 Nov 8;112(19):2980-5. 15 Brock GB, McMahon CG, Chen KK, et al. Efficacy and safety of tadalafil for the treatment of erectile dysfunction: results of integrated analyses. J Urol. 2002 Oct;168(4 Pt 1):1332-6. 16 Tadalafil (cialis) for erectile dysfunction. Med Lett Drugs Ther. 2003 Dec 22;45(1172):101-2. 17 Crowe SM, Streetman DS. Vardenafil treatment for erectile dysfunction. Ann Pharmacother. 2004 Jan;38(1):77-85. 18 Keating GM, Scott LJ. Vardenafil: a review of its use in erectile dysfunction. Drugs. 2003;63(23):2673-703. 19 Hellstrom WJ, Gittelman M, et al. Vardenafil Study Group. Sustained efficacy and tolerability of vardenafil, a highly potent selective phosphodiesterase type 5 inhibitor, in men with erectile dysfunction: results of a

randomized, double-blind, 26-week placebo-controlled pivotal trial. Urology. 2003 Apr;61(4 Suppl 1):8-14. 20 Stark S, Sachse R, Liedl T, Hensen J, et al. Vardenafil increases penile rigidity and tumescence in men with erectile dysfunction after a single oral dose. Eur Urol. 2001 Aug;40(2):181-8; discussion 189-90. 21 Goldstein I, Young JM, et al. Vardenafil Diabetes Study Group. Vardenafil, a new phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction in men with diabetes: a multicenter double-blind placebo-

controlled fixed-dose study. Diabetes Care. 2003 Mar;26(3):777-83. 22 Brock G, Nehra A, Lipshultz LI, Karlin GS, et al. Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. J Urol. 2003 Oct;170(4 Pt 1):1278-83. 23 Markou S, Perimenis P, Gyftopoulos K, Athanasopoulos A, Barbalias G. Vardenafil (Levitra) for erectile dysfunction: a systematic review and meta-analysis of clinical trial reports. Int J Impot Res. 2004 Dec;16(6):470-8. 24 Vardenafil (Levitra) for erectile dysfunction. Med Lett Drugs Ther. 2003 Sep 29;45(1166):77-8. 25 Valiquette L, et al.; Vardenafil Study Group. Sustained efficacy and safety of vardenafil for treatment of erectile dysfunction: a randomized, double-blind, placebo-controlled study. Mayo Clin Proc. 2005 Oct;80(10):1291-7. 26 van Ahlen H, Wahle K, Kupper W, Yassin A, Reblin T, Neureither M. Safety and efficacy of vardenafil, a selective phosphodiesterase 5 inhibitor, in patients with erectile dysfunction and arterial hypertension treated with

multiple antihypertensives. J Sex Med. 2005;2:856-864. 27 Viagra and Loss of Vision. Medical Lett Drugs Ther. 2005 June 20;47(1211):49. FDA July/05 ; Health Canada July/05

June/06 (5CDN cases as of Oct/05) 28 Raina R, Agarwal A, Ausmundson S, et al. Long-term efficacy and compliance of MUSE for erectile dysfunction following radical prostatectomy: SHIM (IIEF-5) analysis. Int J Impot Res. 2005 Feb;17(1):86-90. 29 Steidle C, Padma-Nathan H, Salem S, Tayse N, et al. Topical alprostadil cream for the treatment of erectile dysfunction: a combined analysis of the phase II program. Urology. 2002 Dec;60(6):1077-82. 30 Sommer F, Engelmann U. Future options for combination therapy in the management of erectile dysfunction in older men. Drugs Aging. 2004;21(9):555-64. 31 Jaffe JS, Antell MR, Greenstein M, Ginsberg PC, Mydlo JH, Harkaway RC. Use of intraurethral alprostadil in patients not responding to sildenafil citrate. Urology. 2004 May;63(5):951-4. 32 Urciuoli R, Cantisani TA, CarliniI M, Giuglietti M, Botti FM. Prostaglandin E1 for treatment of erectile dysfunction. Cochrane Database Syst Rev. 2004;(2):CD001784. 33 Jain P, Rademaker AW, McVary KT. Testosterone supplementation for erectile dysfunction: results of a meta-analysis. J Urol. 2000 Aug;164(2):371-5. 34 Ernst E, Pittler MH. Yohimbine for erectile dysfunction: a systematic review and meta-analysis of randomized clinical trials. J Urol. 1998 Feb;159(2):433-6. 35 Milbank AJ, Montague DK. Surgical management of erectile dysfunction. Endocrine. 2004 Mar-Apr;23(2-3):161-5. 36 Erectile Dysfuntion Guideline Update Panel. The management of ED: an Update. American Urological Association, 2005. (Updated 2006) 37 Barada James. Clinical Perspectives on ED. Medscape Conference Coverage ? International Society for Sexual and Impotence Research 11th World Congress, 2005 38 Basson R. Chapter 78: Male Sexual Dysfunction. Therapeutic Choices. CPhA; 2003. 39 Wespes E et al. Guidelines on Erectile Dysfunction. European Urology 2002; 41:1-5. 40 Brock GB et al. Efficacy and safety of tadalafil for treatment of erectile dysfunction: results of integrated analysis. J Urol 2002;168:1332-36. 41 Anderson P et al. New phosphodiesterases inhibitors in the treatment of erectile dysfunction. Expert Opin Pharmacother 2004;5(11):2241-49.

42

Apomorphine

Centrally acting agent

SE: nausea (with time, CR SL tabs);headache,

Onset ................
................

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